WAYNE, PA — Aclaris Therapeutics Inc. (Nasdaq: ACRS) received Fast Track designation from the U.S. Food and Drug Administration for modzatinib as a potential treatment for moderate to severe lichen planus, giving the clinical-stage drug access to an expedited regulatory process as the company prepares to begin a Phase 2b trial in the fourth quarter of 2026.
The designation covers oral erosive lichen planus, cutaneous lichen planus and lichen planopilaris. There are currently no approved therapies for lichen planus, according to Aclaris.
Modzatinib, also known as ATI-2138, is an investigational treatment being developed by the Wayne-based biopharmaceutical company for immuno-inflammatory diseases.
Fast Track status is designed for therapies targeting serious conditions with unmet medical needs. It allows more frequent interactions with the FDA on development plans and clinical trial design and can permit a rolling review of a New Drug Application, in which completed portions are submitted before the entire application is finished.
Programs with the designation may also qualify for Priority Review if they meet the FDA’s applicable criteria.
“Lichen planus is a serious, clinically concerning disease with debilitating symptoms that can affect the quality of life of patients suffering from this disorder,” Chief Medical Officer Jesse Hall said. “Unfortunately, there are currently no approved therapies.”
Aclaris plans to initiate a phased, multi-part Phase 2b study of modzatinib in patients with lichen planus during the fourth quarter. The company expects the Fast Track designation to provide more frequent discussions with regulators as the program advances.
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